A Phase 1, Partially Blinded, Placebo-Controlled, Pharmacokinetic Study of Intravenously Administered BMS-943539-01-001 in Healthy Male Volunteers

All consented patients would be screened up to 14 days prior to randomization. At screening the patients will be assessed on their suitability to enter the study. Assessments preformed include: medical history, physical exam, laboratory assessment, ECG, concomitant and adverse events. Eligable subjects will be randomized. Patients randomised to receive BMS-943539 will be administered the study drug via IV at day 1 and day 15 at different dose levels according to cohort. Cohort 1 will receive 0.1mg/kg. Cohort 2 will receive 0.3mg/Kg. Cohort 3 will receive 1.0mg/Kg Patients will be observed after the 1st infusion on day 1 (observation period 1) and also after the second infusion day 15 (observation period 2). After all the subjects in Cohort 1 have completed their Day 29 visits; the PK findings have been assessed (expected up to 4 weeks); and assuming criteria surpassing the defined no observed adverse event level (NOAEL) have not been met (see below), Cohort 2 will begin the study. Similarly, Cohort 3 will not begin until completion and PK assessment of Cohort 2, assuming the NOAEL has not been surpassed. The NOAEL will be defined as the dose level 1 level below the lowest dose level in which either a) 2 or more actively treated (non-placebo) subjects experience any grade 2 National Cancer Institute (NCI; US)-Common Terminology Criteria for Adverse Events (CTCAE v4.03) BMS-943539-related toxicity or b) at least 1 actively treated subject experiences any grade greater than or equal to 3 BMS-943539-related toxicity. The NOAEL will be the highest dose level completed if neither of these criteria is met. In the case that NOAEL criteria are surpassed in Cohorts 2 or 3, the next lower cohort will be declared the NOAEL and all remaining subjects will be treated at the NOAEL, such that a total of 37 subjects (28 receiving BMS and 9 receiving placebo) are treated in the study. This is in order to maintain the statistical precision sought to support the pharmacokinetic (PK) and immunogenicity research hypotheses, and to support an adequate number of subjects with safety observations. If the dose level of Cohort 1 is found to exceed the NOAEL, then no additional subjects will be dosed and the study will terminate.